Methods and devices for facilitating visualization in a surgical environment

ABSTRACT

Devices and methods for visually confirming the positioning of a distal end portion of an illuminating device placed within a patient include inserting a distal end portion of an illuminating device internally into a patient, emitting light from the distal end portion of the illuminating device, observing transillumination resulting from the light emitted from the distal end portion of the illuminating device that occurs on an external surface of the patient, and correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination, to confirm positioning of the distal end portion of the illuminating device.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods and more particularly to methods and devices for performingminimally invasive procedures that reduce the need to providefluoroscopic or other radiographic visualization.

BACKGROUND OF THE INVENTION

The skull contains a series of cavities known as paranasal sinuses thatare connected by passageways. The paranasal sinuses include frontalsinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses. Theparanasal sinuses are lined with mucous-producing mucosal tissue andultimately open into the nasal cavity. Normally, mucous produced by themucosal tissue slowly drains out of each sinus through an opening knownas an ostium. If the mucosal tissue of one of these passageways becomesinflamed for any reason, the cavities which drain through thatpassageway can become blocked. This blockage can be periodic (resultingin episodes of pain) or chronic. This interference with drainage ofmucous (e.g., occlusion of a sinus ostium) can result in mucosalcongestion within the paranasal sinuses. Chronic mucosal congestion ofthe sinuses can cause damage to the epithelium that lines the sinus withsubsequent decreased oxygen tension and microbial growth (e.g., a sinusinfection).

The term “sinusitis” refers generally to any inflammation or infectionof the paranasal sinuses caused by bacteria, viruses, fungi (molds),allergies or combinations thereof. It has been estimated that chronicsinusitis (e.g., lasting more than 3 months or so) results in 18 millionto 22 million physician office visits per year in the United States.Patients who suffer from sinusitis typically experience at least some ofthe following symptoms: headaches or facial pain; nasal congestion orpost-nasal drainage: difficulty breathing through one or both nostrils;bad breath; and/or pain in the upper teeth.

One of the ways to treat sinusitis is by restoring the lost mucous flow.The initial therapy is typically drug therapy using anti-inflammatoryagents to reduce the inflammation and antibiotics to treat theinfection. A large number of patients do not respond to drug therapy.Currently, the gold standard for patients with chronic sinusitis that donot respond to drug therapy is a corrective surgery called FunctionalEndoscopic Sinus Surgery (FESS).

During FESS, an endoscope is inserted into the nose and, undervisualization through the endoscope, the surgeon may remove diseased orhypertrophic tissue or bone and may enlarge the ostia of the sinuses torestore normal drainage of the sinuses. FESS procedures are typicallyperformed with the patient under general anesthesia.

Although FESS continues to be the gold standard therapy for surgicaltreatment of severe sinus disease, FESS does have several shortcomings.For example, FESS can cause significant post-operative pain. Also, someFESS procedures are associated with significant postoperative bleedingand, as a result, nasal packing is frequently placed in the patient'snose for some period of time following the surgery. Such nasal packingcan be uncomfortable and can interfere with normal breathing, eating,drinking etc. Also, some patients remain symptomatic even after multipleFESS surgeries. Additionally, some FESS procedures are associated withrisks of iatrogenic orbital, intracranial and sinonasal injury. Manyotolaryngologists consider FESS an option only for patients who sufferfrom severe sinus disease (e.g., those showing significant abnormalitiesunder CT scan). Thus, patients with less severe disease may not beconsidered candidates for FESS. One of the reasons why FESS procedurescan be bloody and painful relates to the fact that instruments havingstraight, rigid shafts are used. In order to target deep areas of theanatomy with such straight rigid instrumentation, the physician needs toresect and remove or otherwise manipulate any anatomical structures thatmay lie in the direct path of the instruments, regardless of whetherthose anatomical structures are part of the pathology.

New devices, systems and techniques are being developed for thetreatment of sinusitis and other disorders of the ear, nose, throat andparanasal sinuses. For example, various catheters, guidewires and otherdevices useable to perform minimally invasive, minimally traumatic ear,nose and throat surgery have been described in U.S. patent applicationsSer. No. 10/829,917 entitled “Devices, Systems and Methods forDiagnosing and Treating Sinusitis and Other Disorders of the Ears, Noseand/or Throat,” Ser. No. 10/912,578 entitled “Implantable Device andMethods for Delivering Drugs and Other Substances to Treat Sinusitis andOther Disorders,” Ser. No. 10/944,270 entitled “Apparatus and Methodsfor Dilating and Modifying Ostia of Paranasal Sinuses and OtherIntranasal or Paranasal Structures” Ser. No. 11/037,548 entitled“Devices, Systems and Methods For Treating Disorders of the Ear, Noseand Throat”, and Ser. No. 11/116,118 entitled “Methods and Devices ForPerforming Procedures Within the Ear, Nose, Throat and ParanasalSinuses”. Each of these applications is hereby incorporated herein, inits entirety, by reference thereto. Many of these new devices, systemsand techniques are useable in conjunction with endoscopic, radiographicand/or electronic assistance to facilitate precise positioning andmovement of catheters, guidewires and other devices within the ear,nose, throat and paranasal sinuses and to avoid undesirable trauma ordamage to critical anatomical structures such as the eyes, facial nervesand brain.

For example, in one new procedure (referred to in this patentapplication as a “Flexible Transnasal Sinus Intervention” or FTSI), adilatation catheter (e.g., a balloon catheter or other type of dilator)is advanced through the nose to a position within the ostium of aparanasal sinus or other location, without requiring removal or surgicalalteration of other intranasal anatomical structures. The dilatationcatheter is then used to dilate the ostium or other anatomicalstructures to facilitate natural drainage from the sinus cavity. In somecases, a tubular guide may be initially inserted through the nose andadvanced to a position near the sinus ostium and a guidewire may then beadvanced through the tubular guide and into the affected paranasalsinus. The dilatation catheter may then be advanced over the guidewireand through the tubular guide to a position where its dilator (e.g.,balloon) is positioned within the sinus ostium. The dilator (e.g.,balloon) is then expanded causing the ostium to dilate. In some cases,such dilatation of the ostium may fracture, move or remodel bonystructures that surround or are adjacent to the ostium. Optionally, insome procedures, irrigation solution and/or therapeutic agents may beinfused through a lumen of the dilatation catheter and/or other workingdevices (e.g., guidewires, catheters, cannula, tubes, dilators,balloons, substance injectors, needles, penetrators, cutters, debriders,microdebriders, hemostatic devices, cautery devices, cryosurgicaldevices, heaters, coolers, scopes, endoscopes, light guides,phototherapy devices, drills, rasps, saws, etc.) may be advanced throughthe tubular guide and/or over the guidewire to deliver other therapy tothe sinus or adjacent tissues during the same procedure in which theFTSI is carried out. It is to be understood that, in FTSI procedures,structures and passageways other than sinus ostia may be dilated usingthe tools described above, tissue may be resected or ablated, bone maybe restructured, drugs or drug delivery systems may be deployed, etc.,as described in the documents incorporated herein by reference. Thus,for the purposes of this application the term FTSI will be generallyused to refer broadly to all of those procedures, not just dilation ofsinus ostia.

In FTSI procedures that include positioning of a guidewire into aparanasal sinus, the placement of the guidewire is typically confirmedby visualizing the procedure under fluoroscopy or other x-rayvisualization technique, for example. Appropriate positioning of thetubular guide at the position near the sinus ostium may also beconfirmed via fluoroscopy. In order to reduce the radiation exposure tothe patient undergoing the procedure, and particularly to the surgeonand other personnel that carry out many of these types of procedures,there is a need for methods and devices that eliminate or reduce theneed to use fluoroscopic visualization during such procedures.

SUMMARY OF THE INVENTION

A method for visually confirming the positioning of a distal end portionof a device placed within a patient is provided to include: inserting adistal end portion of an illuminating device internally into a patient,emitting light from the distal end portion of the illuminating device;observing transillumination resulting from the light emitted from thedistal end portion of the illuminating device that occurs on an externalsurface of the patient; and correlating the location of the observedtransillumination on the external surface of the patient with aninternal location of the patient that underlies the location of observedtransillumination, to confirm positioning of the distal end portion ofthe illuminating device.

In at least one embodiment, the observation is performed by direct lineof sight human observation, without the need for fluoroscopy.

In at least one embodiment, the observation is performed by direct lineof sight human observation, without the need for any visualizationequipment.

In at least one embodiment, the illuminating device comprises aguidewire.

In at least one embodiment, the illuminating device comprises an ostiumseeker device.

In at least one embodiment, the illuminating device comprises a sinussuction instrument.

In at least one embodiment, the illuminating device comprises anintegrated wire dilatation catheter, wherein an integrated illuminatingguidewire extends distally of a distal end of a dilatation catheter.

In at least one embodiment, the distal end portion of the illuminatingguidewire is inserted into a sinus passageway of the patient.

In at least one embodiment, the distal end portion of the illuminatingguidewire is inserted through an ostium opening to a sinus of thepatient, and the distal end portion is advanced into the sinus.

In at least one embodiment, the distal end portion of the illuminatingguidewire is initially inserted through a nostril of the patient andthen advanced into a sinus.

In at least one embodiment, a scope is inserted through the nostril ofthe patient, wherein the guidewire is inserted adjacent the scope, andvisualization of the advancement of the distal end portion of theguidewire is performed via the scope as the distal end portion isadvanced toward an ostium of the sinus.

In at least one embodiment, transillumination is observed when a lightemitting portion of the distal end portion is located in the sinus ofthe patient.

If observation of transillumination and correlation reveals that thedistal end portion of the illumination device has been misrouted to alocation other than a target location, distal end portion of the devicecan be retracted and re-routed to the target location, which can beconfirmed by observing transillumination and correlating.

In observing transillumination, the motion of the transillumination spotresulting from the light emitted from the distal end portion of theilluminating device can be observed and tracked or followed visually, asthe distal end portion is moved relative to the patient, and this can beone way of confirming that the transillumination spot in motioncorrelates to a position of the distal end portion. This technique canbe particularly useful when there are additional sources oftransillumination, such as a light from a scope, for example.

Further, transillumination resulting from the light emitted from thedistal end portion of the device can be distinguished fromtransillumination resulting from light emitted from a scope byidentifying a transillumination spot that is at least one of brighter,smaller or more well-defined than other transillumination effectsobserved. Alternatively, the transillumination resulting from the lightemitted from the distal end portion of the device can be distinguishedfrom transillumination resulting from light emitted from a scope byturning off or down the light source to the scope.

In at least one embodiment, a sinus guide is inserted within the patientprior to inserting the device, and the distal end portion of theilluminating device is inserted through the sinus guide.

In at least one embodiment, the illuminating device is preloaded in theguide, and the guide and preloaded illuminating device are insertedtogether into the patient. Advancement of the illuminating devicerelative to the guide can then be performed to extend a distal endportion of the illuminating device distally of a distal end of theguide.

A scope may be inserted within the patient, wherein the sinus guide isinserted adjacent the scope, and advancement of the sinus guide can bevisualized via the scope.

In at least one embodiment, visualization of the advancement of thesinus guide is through use of the scope, up to a limit of adequateillumination by the scope. After that, the light emitted by the distalend portion of the illuminating device, having been advanced distally ofa distal end of the sinus guide, extends the limit of adequateillumination of the scope, thereby extending a length of the adequateillumination of the scope.

In at least one embodiment, the sinus guide can be further distallyadvanced under visualization by the scope as facilitated by the extendedlength of the adequate illumination.

In at least one embodiment, visualization of the advancement of theilluminating device distally of the sinus guide can be performed via thescope, as facilitated by the light emitted from the distal end portionof the device.

In at least one embodiment, the scope is inserted into a nostril of thepatient, and the sinus guide is inserted adjacent the scope.

In at least one embodiment, the scope and sinus guide are advanced intoa sinus passageway of the patient.

In at least one embodiment, the sinus guide is further advanced towardan ostium of a sinus, and the advancement of the sinus guide is visuallyobserved via the scope.

In at least one embodiment, the scope is inserted into a nostril of thepatient, and the sinus guide is inserted adjacent the scope. Theadvancement of the sinus guide into a sinus passageway is visualized viathe scope until a distal end of the sinus guide has reached a distallimit of illumination emitted by the scope.

In at least one embodiment, further advancement of the sinus guidetoward an ostium of a sinus is visualized via the scope as facilitatedby the extended length of adequate illumination provided by theillumination device.

In at least one embodiment, the scope is inserted into a nostril of thepatient, and the sinus guide is inserted adjacent the scope. Theadvancement of the sinus guide to place a distal end of the sinus guideadjacent an approach to an ostium of a sinus is visualized via thescope.

In at least one embodiment, the distal end portion of the illuminatingdevice is advanced further distally of a distal end of the sinus guideand distal of the limit of illumination of the scope to emitillumination, thereby extending a length of a space that is visualizableby the scope.

In at least one embodiment, the distal end portion of the device isfurther advanced into and through the ostium, and visualization of theadvancement of the distal end portion into the ostium is performed viathe scope.

In at least one embodiment the device comprises an illuminatingguidewire, a working device is advanced over the guidewire to position aworking end of the working device at a target location, and a surgicalprocedure is performed with the working device at the target location.The working device is removed from the patient after performing thesurgical procedure. Optionally, an implant can be left at the targetlocation.

A method of performing a minimally invasive surgical procedure isprovided, including the steps of: inserting a distal end portion of anilluminating guidewire internally into a patient; emitting light fromthe distal end portion of the illuminating guidewire, wherein a proximalend portion is connected to a power source to enable the distal endportion to emit light; observing transillumination resulting from thelight emitted from the distal end portion of the illuminating guidewirethat occurs on an external surface of the patient; correlating thelocation of the observed transillumination on the external surface ofthe patient with an internal location of the patient that underlies thelocation of observed transillumination, to confirm positioning of thedistal end portion of the illuminating guidewire; disconnecting theproximal end portion of the illuminating guidewire from the powersource; advancing a working device over the guidewire so that a proximalend of the guidewire extends proximally from the working device;reconnecting the proximal end portion of the illuminating guidewire tothe power source so that the distal end portion of the guidewire againemits light; positioning a working end of the working device at a targetlocation; and performing a surgical procedure with the working device atthe target location.

After performing the surgical procedure, the proximal end portion of theilluminating guidewire is disconnected from the power source; and theworking device is removed from the patient and from the guidewire.Optionally, an implant can be left at the target location.

In at least one embodiment, a second working device is advanced over theguidewire after removing the first working device therefrom, so that aproximal end of the guidewire extends proximally from the second workingdevice. Then the proximal end portion of the illuminating guidewire isreconnected to the power source so that the distal end portion of theguidewire again emits light.

In at least one embodiment, the illuminating guidewire includes at leastone illumination fiber extending from a proximal end of the guidewire tothe distal end portion, and the power source is a light source.

In at least one embodiment, the illuminating guidewire includes at leastone laser fiber extending from a proximal end of the guidewire to thedistal end portion, and the power source is a laser light source.

In at least one embodiment, the illuminating guidewire includes a lightemitting diode at the distal end portion and electrical wires extendingthrough the guidewire, electrically connecting the light emitting diodeto the power source, and wherein the power source is an electrical powersource.

A method for diagnosing and/or treating sinusitis or another disorderaffecting a nose, a sinus or other anatomical structure of the ear, noseor throat in a human or animal patient is provided, including the stepsof: advancing an introducing device through the nose and to a positionwhere the distal end of the introducing device is near an opening of asinus; advancing a distal end portion of an illuminating device thatemits light from the distal end portion thereof through the introducingdevice while a proximal end of the illuminating device is connected to apower source; and monitoring a position of the distal end portion of theilluminating device distally of the distal end of the introducingdevice, by observing transillumination on an external surface of thepatient that results from the light emitted by the distal end portion.The light emitted can be a desired wavelength in the visible spectrumand/or infrared spectrum.

In at least one embodiment, the distal end portion of the illuminatingdevice is advanced through the opening of the sinus; and placement ofthe distal end portion of the illuminating device in the sinus isconfirmed by observing the transillumination resulting from the lightemitted from the distal end portion of the illuminating device thatoccurs on the external surface of the patient, and correlating thelocation of the observed transillumination on the external surface ofthe patient with an internal location of the patient that underlies thelocation of observed transillumination.

In at least one embodiment, the external surface on which thetransillumination is observed is on the face of the patient.

In at least one embodiment, the external surface on which thetransillumination is observed is on the palate of the patient.

In at least one embodiment the illuminating device comprises anilluminating guidewire, and a working device is provided that ispositionable in an operative location and useable to perform adiagnostic or therapeutic procedure there. The proximal end of theilluminating guidewire is disconnected from the power source, whilemaintaining the distal end portion of the illuminating guidewire in itscurrent position, and the working device is advanced over the guidewireso that a proximal end of the guidewire extends proximally from theworking device. The proximal end of the illuminating guidewire is thenreconnected to the power source so that the distal end portion of theguidewire again emits light. The working device is further advanced toposition a working end of the working device at the operative location,and a diagnostic or therapeutic procedure is performed with the workingdevice at the operative location.

In at least one embodiment, the operative location is the opening to thesinus.

An illuminating guidewire device is provided, including: a flexibledistal end portion; a relatively less flexible proximal end portion; atleast one light emitting element in the distal end portion; and at leastone structure extending from a proximal end of the device through theproximal end portion and at least part of the distal end portion toconnect the at least one light emitting element with a power sourcelocated proximally of the device.

In at least one embodiment, the at least one light emitting elementcomprises a distal end of at least one illumination fiber, and the atleast one structure comprises the at least one illumination fiberrunning proximally of the distal end of the fiber to the proximal end ofthe device.

In at least one embodiment, the power source is a light source.

In at least one embodiment, the at least one light emitting element ofthe illuminating guidewire comprises a distal end of at least one laserfiber, and the at least one structure comprises the at least one laserfiber running proximally from the distal end of the fiber to theproximal end of said device.

In at least one embodiment, the power source is a laser light source.

In at least one embodiment, the at least one light emitting elementcomprises a light emitting diode, and the at least one structurecomprises at least one electrical wire electrically connected to thelight emitting diode and extending proximally of the light emittingdiode to the proximal end of the device.

In at least one embodiment, the power source is an electrical powersource.

In at least one embodiment, the distal end portion of the guidewire hasan outside diameter configured and dimensioned to pass through an ostiumof a sinus.

In at least one embodiment, the distal end portion of the guidewire hasan outside diameter less than about 0.038 inches.

In at least one embodiment, the distal end portion of the guidewire hasan outside diameter of about 0.035″±0.005″.

In at least one embodiment, the illuminating guidewire has a maximumoutside diameter of less than about 0.038 inches.

In at least one embodiment, the illuminating guidewire has a maximumoutside diameter of less than about 0.035 inches.

In at least one embodiment, the illuminating guidewire has a maximumoutside diameter of about 0.035″±0.005″.

In at least one embodiment, the distal end portion of the devicecomprises a flexible coil. In at least one embodiment, the distal endportion further comprises a core support extending internally of thecoil. In at least one embodiment, the core support is fixed to the coil.

In at least one embodiment, a core support extending within the distaland proximal end portions of the device. In at least one embodiment, thecore support extends within substantially the full length of the distaland proximal end portions.

In at least one embodiment, the distal end portion of the deviceincludes a bend, such that a proximal part of the distal end portion issubstantially aligned with a longitudinal axis of the device, and adistal part of the distal end portion is angled with respect to thelongitudinal axis.

In at least one embodiment, the distal end of at least one illuminationfiber is configured to emit light from a distal tip of the distal endportion of the device.

The distal tip can be designed to either focus or distribute the lightto achieve maximum transillumination. The distal tip can include a lens,prism or diffracting element.

In at least one embodiment, the distal end of at least one illuminationfiber is positioned proximally of a distal tip of the distal end portionof the device.

In at least one embodiment, a flexible distal portion of the distal endportion extends distally of the distal end of the at least oneillumination fiber.

In at least one embodiment, the distal end of at least one laser fiberis configured to emit light from a distal tip of the distal end portionof the device.

In at least one embodiment, the distal end of at least one laser fiberis positioned proximally of a distal tip of the distal end portion ofthe device.

In at least one embodiment, a flexible distal portion of the distal endportion extends distally of the distal end of at least one illuminationfiber.

In at least one embodiment, a light emitting diode is mounted at adistal tip of the distal end portion of the device.

In at least one embodiment, a light emitting diode is positionedproximally of a distal tip of the distal end portion of the device. Inat least one embodiment, a flexible distal portion of the distal endportion extends distally of the light emitting diode.

In at least one embodiment, an electrical power source is removably,electrically connected to at least one structure to provide electricalpower to at least one light emitting element.

In at least one embodiment, at least one light conducting tube deliverslight from a proximal end portion of the device to a distal and of thetube, where it is emitted.

In at least one embodiment, each light conducting tube is sealed in aproximal end of the device.

In at least one embodiment, each light emitting element is sealed at adistal tip of the device.

In at least one embodiment, a quick release connector is mounted over atleast part of the proximal end portion of the guidewire. The quickrelease connector is adapted to be connected to a power source and toquickly connect to and release from the proximal end portion of theguidewire.

In at least one embodiment, the quick release connector is opticallycoupled with a light source.

In at least one embodiment, the proximal end portion of the quickrelease connector is adapted to connect with a light source.

In at least one embodiment, the proximal end portion of the quickrelease connector comprises an ACMI light post.

In at least one embodiment, the connector is rotatable with respect to alight channel extending from a light source, when the connector isconnected to the light channel. In at least one embodiment, the lightcable comprises a fluid filled light cable.

In at least one embodiment, a distal end portion of the connectorcomprises an opening configured to slidably receive the proximal endportion of the guidewire device; and a quick release locking mechanismis configured to fix the proximal end portion received in the connector.

In at least one embodiment, the quick release locking mechanism ismovable between an unlocked configuration in which the proximal endportion can be slid from the connector to disconnect therefrom, and alocked configuration that maintains the proximal end portion inconnection with the connector. In at least one embodiment, the quickrelease locking mechanism is biased toward the locked configuration.

In at least one embodiment, a radiopaque marker is provided on thedistal end portion of the guidewire.

In at least one embodiment, an electromagnetic coil is provided at thedistal end portion of the guidewire. Alternatively, a magnet,radiofrequency emitter or ultrasound crystal can be provided at thedistal end portion of the guidewire.

An illuminating device is provided, including a distal end portionhaving an outside diameter configured and dimensioned to pass through anostium of a sinus, at least one light emitting element in the distal endportion, and at least one structure extending from a proximal end of thedevice through the proximal end portion and at least part of the distalend portion to connect the at least one light emitting element with apower source.

In at least one embodiment, the illuminating device comprises anilluminating guidewire.

In at least one embodiment, the illuminating device comprises an ostiumseeker device, and the distal end portion is rigid or malleable.

In at least one embodiment, the illuminating device comprises an ostiumseeker device, and the distal end portion comprises a ball tip at adistal end thereof.

In at least one embodiment, the illuminating device comprises a sinussuction instrument, and the distal end portion further comprises asuction lumen configured and adapted to apply suction therethrough.

In at least one embodiment, the illuminating device comprises anintegrated wire dilatation catheter, wherein an integrated illuminatingguidewire extends distally of a distal end of a dilatation catheter ofthe device.

An illuminating guidewire device is provided including: a guidewireincluding an elongated main body having a flexible distal end portionand a relatively less flexible proximal end portion; at least one lightconducting channel extending the length of the elongated body, andconfigured and dimensioned to deliver light from a proximal end of theguidewire to a distal end of the guidewire and to emit light from thedistal end of the guidewire.

In at least one embodiment, the at least one light conducting channelcomprises at least one illumination fiber.

In at least one embodiment, the at least one light conducting channelcomprises at least two illumination fibers.

In at least one embodiment, the illumination fibers are formed ofplastic.

In at least one embodiment, the at least one illumination fiber isformed of glass.

In at least one embodiment, the at least one light conducting channelcomprises at least one laser fiber.

In at least one embodiment, a quick release connector is mounted over atleast part of the proximal end portion of the elongated body, and isadapted to be connected to a light channel extending from a lightsource; and to quickly connect to and release from the proximal endportion of the elongated body.

In at least one embodiment, the quick release connector is opticallycoupled with the light source.

In at least one embodiment, a proximal end portion of the connectorcomprises a tapering light channel configured to adapt a relativelylarger inside diameter of the light channel to a relatively smallerdiameter of the proximal end of the elongated body.

In at least one embodiment, a proximal end portion of the quick releaseconnector is adapted to connect with a light source. In at least oneembodiment, the proximal end portion of the quick release connectorincludes an ACMI light post.

In at least one embodiment, the connector is rotatable with respect tothe light channel extending from the light source, when the connector isconnected to the light channel.

In at least one embodiment, the distal end portion of the connectorcomprises an opening configured to slidably receive the proximal endportion of the elongated body, and a quick release locking mechanism isconfigured to fix the proximal end portion received in the connector.

In at least one embodiment, the quick release locking mechanism, in alocked configuration, maintains a proximal end of the elongated body inalignment with a distal end of the tapering light channel of theconnector.

In at least one embodiment, the quick release locking mechanism ismovable between an unlocked configuration in which the proximal endportion can be slid from the connector to disconnect therefrom, and alocked configuration that maintains the proximal end portion inconnection with the connector.

In at least one embodiment, a core support extends at least within thedistal end portion of the elongated body of the guidewire. In at leastone embodiment, the core support further extends within the proximal endportion.

An illuminating guidewire device is provided, including: a guidewirehaving an elongated main body with a flexible distal end portion and arelatively less flexible proximal end portion; a light emitting diodemounted in the distal end portion and configured to emit light from adistal tip of the distal end portion; and at least one electrical wireextending the length of the elongated body, being electrically connectedto the light emitting diode, and extending proximally of a proximal endof the elongated body.

In at least one embodiment, the illuminating guidewire device includesat least two such electrical wires.

In at least one embodiment, a core support extends at least within thedistal end portion of the elongated body. In at least one embodiment,the core support further extends within the proximal end portion.

In at least one embodiment, a radiopaque marker is provided on thedistal end portion. In at least one embodiment, an electromagnetic coilis provided on the distal end portion.

An illuminating guidewire device is provided, including: a guidewirehaving a flexible distal end portion, a relatively less flexibleproximal end portion, and a transparent portion interconnecting thedistal and proximal end portions; a least one light emitting elementmounted in the guidewire and configured to emit light through thetransparent portion; and at least one structure extending from aproximal end of the device through the proximal end portion andconnecting with the at least one light emitting element.

In at least one embodiment, the transparent portion comprises a cleartube.

In at least one embodiment, the clear tube includes cut out windowstherein.

In at least one embodiment, the transparent portion comprises aplurality of struts interconnecting the proximal and distal end portionsof the guidewire.

In at least one embodiment, a deflector is mounted distally of the atleast one light emitting element in the transparent portion.

In at least one embodiment, a quick release connector is mounted over atleast part of the proximal end portion, and is adapted to be connectedto a light channel extending from a light source, and to quickly connectto and release from the proximal end portion of the guidewire.

In at least one embodiment, a core support extends at least within thedistal end portion. In at least one embodiment, the core support furtherextends within the proximal end portion.

A quick release connector for use with an illuminating guidewire isprovided to include: a main body having a proximal end portion and adistal end portion; a channel in the distal end portion and opening to adistal end of the main body, wherein the channel is configured anddimensioned to slidably receive a proximal end portion of theilluminating guidewire; and a quick release locking mechanism configuredto assume a locked position and an unlocked position, wherein when inthe locked position, the quick release locking mechanism fixes theproximal end portion of the illuminating guidewire in the channel.

In at least one embodiment, the quick release locking mechanism isbiased to the locked position.

In at least one embodiment, upon inserting the proximal end portion ofthe illuminating guidewire into the channel, the proximal end portioncontacts portions of the quick release locking mechanism, driving theportions apart to allow the proximal end portion to be slid into thechannel.

In at least one embodiment, the quick release locking mechanismcomprises a locking arm that extends into the channel and a portion thatextends out of the housing, wherein the portion extending out of thehousing is manually retractable to move the locking arm from the lockedposition to the unlocked position.

In at least one embodiment, the quick release locking mechanism includesat least two locking arms provided circumferentially about the distalend portion of the main body of the connector.

In at least one embodiment, the quick release locking mechanismcomprises a pin vise.

In at least one embodiment, the proximal end portion of the connector isadapted to be connected to a light channel extending from a lightsource.

In at least one embodiment, the proximal end portion of the main body isoptically coupled with a light source.

In at least one embodiment, the proximal end portion of the main bodyincludes a tapering light channel configured to adapt a relativelylarger inside diameter of a light channel to a relatively smallerdiameter of the proximal end of the illuminating guidewire.

In at least one embodiment, the proximal end portion of the main bodycomprises an ACMI light post.

In at least one embodiment, the quick release connector is rotatablewith respect to a light channel extending from a light source, when theconnector is connected to the light channel.

These and other advantages and features of the invention will becomeapparent to those persons skilled in the art upon reading the details ofthe devices, methods and systems as more fully described below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a patient being treated by a system forcatheter-based minimally invasive sinus surgery according to prior arttechniques.

FIGS. 2A through 2D are illustrations of partial sagittal sectionalviews through a human head showing various steps of a method of gainingaccess to a paranasal sinus using a sinus guide.

FIG. 3 illustrates a scope introduced on the side of the sinus guide.

FIG. 4 shows an illuminating guidewire according to one embodiment ofthe present invention.

FIG. 5 shows a distal end portion of a guidewire having a bent shape.

FIG. 6 is a cross-sectional illustration of a distal end portion of aguidewire device showing a core support fixed to the coil.

FIG. 7 shows a cross-sectional view of a guidewire device that includesa fiber optic bundle of light fibers.

FIG. 8 shows an illuminating guidewire according to another embodimentof the present invention.

FIG. 9 is a cross-sectional illustration of a distal end portion of theguidewire shown in FIG. 8.

FIG. 10 shows an illuminating guidewire according to another embodimentof the present invention.

FIG. 11 illustrates an alternative transparent portion that may beincluded in a device shown in FIG. 10.

FIG. 12 illustrates another alternative transparent portion that may beincluded in a device shown in FIG. 10.

FIG. 13A illustrates an illuminating guidewire device including a quickrelease connector that is optically coupled to a light source.

FIG. 13B is a view of the arrangement of FIG. 13A in which the quickrelease locking mechanism is in the locked position.

FIG. 14A illustrates an alternative quick release connector.

FIG. 14B illustrates the connector of FIG. 14A mounted over a proximalend portion of an illuminating guidewire.

FIG. 15 illustrates another alternative quick release connector.

FIG. 16 illustrates another alternative quick release connector.

FIGS. 17A-17E are illustrations of partial coronal sectional viewsthrough a human head showing various steps of a method for treating anostium that opens to a frontal sinus.

FIG. 18 illustrates a situation, like that described with regard to FIG.3, where a scope has been inserted as far as possible without causingsignificant trauma to the patient. Additionally, FIG. 18 shows anilluminating guidewire having been extended distally of the limit ofillumination of the scope, to effectively extend the illuminationdistance viewable by the scope.

FIG. 19 illustrates non-limiting examples of where one or more filtersmay be placed in an illuminating guidewire device.

FIG. 20A schematically illustrates a connector having a rotating shutterrotatably mounted therein.

FIG. 20B is an illustration of a plan view of the shutter of FIG. 20A.

FIG. 21 shows a frontal ostium seeker instrument that can be used toaccess a sinus ostium.

FIG. 22 shows a suction sinus instrument that is configured to evacuateblood and/or other fluids from a target surgical site, such as thefrontal sinus.

FIG. 23 shows an integrated wire dilatation catheter 120 that includesan elongate, flexible catheter shaft having a balloon mounted thereon.

DETAILED DESCRIPTION OF THE INVENTION

Before the present devices and methods are described, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are now described. All publications mentioned herein areincorporated herein by reference to disclose and describe the methodsand/or materials in connection with which the publications are cited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “atube” includes a plurality of such tubes and reference to “the shaft”includes reference to one or more shafts and equivalents thereof knownto those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

Turning now to FIG. 1, an illustration of a patient being treated by asystem for catheter-based minimally invasive sinus surgery according toprior art techniques is shown. A C-arm fluoroscope 1000 that is useableto visualize a first introducing device 1002 (e.g., a sinus guide, guidecatheter or guide tube), a second introducing device 1004 (e.g., aguidewire or elongated probe) and a working device 1006 (e.g., a ballooncatheter, other dilatation catheter, debrider, cutter, etc.). The sinusguide, guide catheter or guide tube 1002 may be introduced under directvisualization, visualization provided by fluoroscope 1000 and/or fromendoscopic visualization, to place the distal end of catheter or tube1002 at a location approaching an ostium of a sinus to be treated.

Next guidewire or elongated probe 1004 is inserted through catheter ortube 1002 and distally advanced to extend the distal end of guidewire orelongated probe through the ostium to be treated and into the sinus thatthe ostium opens to. Proper placement often involves advancement andretraction of the distal end of guidewire or elongated probe, underfluoroscopic visualization, until it has been visually confirmed thatthe distal end of the guidewire or elongated probe is located where thesurgeon believes the appropriate sinus to be located, relative to theother features of the patient's head that are visualized underfluoroscopy.

Once guidewire or elongated probe 1004 has been properly placed, workingdevice 1006 is next passed over the guidewire or elongated probe 1006,under visualization via fluoroscope 1000 and/or an endoscope (not shown)that has been inserted adjacent catheter or tube 1002, to place theworking end of working device 1006 in the target location where asurgical procedure is to be performed. Typically, the guidewire orelongated probe remains in place during the procedure. Under the sametype(s) of visualization, the working (distal) end of working device isthen actuated to perform the desired surgical procedure. In the case ofa dilatation catheter, the balloon at the distal end portion of catheter1006 is expanded once it has been located across the ostium. Thisexpansion acts to open the ostium to allow proper mucus flow, as wasdescribed in more detail above.

After performance of the desired surgical procedure, the working device1006 is deactivated and withdrawn from the patient, after which theremaining devices are withdrawn to complete the procedure.

By using the devices and methods described herein, at least the need forfluoroscopic visualization of the placement of the guidewire/elongatedprobe can be reduced or eliminated. Further optionally, all fluoroscopicvisualization needs may be eliminated in some surgical circumstances.

It is to be appreciated that the devices and methods of the presentinvention relate to the accessing and dilatation or modification ofsinus ostia or other passageways within the ear, nose and throat. Thesedevices and methods may be used alone or may be used in conjunction withother surgical or non-surgical treatments, including but not limited tothe delivery or implantation of devices and drugs or other substances asdescribed in co-pending U.S. patent application Ser. No. 10/912,578.

FIGS. 2A through 2D are illustrations of partial sagittal sectionalviews through a human head showing various steps of a method of gainingaccess to a paranasal sinus using a sinus guide. In FIG. 2A, a firstintroducing device in the form of a sinus guide 1002 is introducedthrough a nostril and through a nasal cavity 1012 to a location close toan ostium 1014 of a sphenoid sinus 1016. Sinus guide 1002 may bestraight, malleable, or it may incorporate one or more preformed curvesor bends as further described in U.S. Patent Publication Nos.2006/004323; 2006/0063973; and 2006/0095066, for example, each of whichare incorporated herein, in their entireties, by reference thereto. Inembodiments where sinus guide 1002 is curved or bent, the deflectionangle of the curve or bend may be in the range of up to about 135degrees.

In FIG. 2B, a second introduction device comprising a guidewire 10 isintroduced through the first introduction device (i.e., sinus guide1002) and advanced so that the distal end portion of guidewire 10 entersthe sphenoid sinus 1016 through the ostium 1014.

In FIG. 2C, a working device 1006, for example a balloon catheter, isintroduced over guidewire 10 and advanced to extend the distal endportion of device 1006 into the sphenoid sinus 1016. Thereafter, in FIG.2D, working device 1006 is used to perform a diagnostic or therapeuticprocedure. In this particular example, the procedure is dilatation ofthe sphenoid sinus ostium 1014, as is illustrated in FIG. 2D, where theballoon of device 1006 is expanded to enlarge the opening of the ostium1014. After completion of the procedure, sinus guide 1002, guidewire 10and working device 1006 are withdrawn and removed. It will beappreciated that the present invention may also be used to dilate ormodify any sinus ostium or other man-made or naturally occurringanatomical opening or passageway within the nose, paranasal sinuses,nasopharynx or adjacent areas. As will also be appreciated by those ofordinary skill in the art, in this or any of the procedures described inthis patent application, the operator may additionally advance othertypes of catheters, and that guidewire 10 may be steerable (e.g.torquable, actively deformable) or shapeable or malleable.

FIGS. 2B-2D show an optional scope 1008 in dotted lines, that may beinserted to provide visualization of advancement of sinus guide 1002and/or inserted alongside catheter 1002 to provide visualization of allor at least a portion of working tool 1006. It is to be appreciated thatoptional scope 1008 may comprise any suitable types of rigid or flexibleendoscope and such optional scope may be separate from or incorporatedinto the working devices and/or introduction devices of the presentinvention, as further described in co-pending provisional ApplicationSerial No. (Application Serial No. not yet assigned, Attorney's DocketNo. ACCL-003PRV) titled “Endoscopic Methods and Devices for TransnasalProcedures, filed concurrently herewith, and which is herebyincorporated herein, in its entirety, by reference thereto.

Although scope 1008 may be useful to reduce or eliminate the need forfluoroscopic visualization during placement of sinus guide 1002 and/orfor visualization of the procedure performed by working device 1006, itdoes not provide stand-alone capability to see inside the sinus (e.g.,sphenoid sinus 1016 or other sinus of interest), and therefore cannotprovide sufficient visual feedback for use in guiding guidewire 10 intothe desired sinus (e.g., frontal sinus, or some other sinus of interest)or sufficient visual image confirmation of correct placement ofguidewire 10 into the desired sinus.

Further, depending upon the particular configuration of the sinuspassageways to be traversed to gain access to a target ostium, the scope1008, due to physical limitations (e.g., outside diameter, degree ofrigidity, etc.) may be unable to visualize as deep as the location ofthe ostium of interest. For example, FIG. 3 illustrates a situationwhere scope 1008 has been inserted as far as possible without causingsignificant trauma to the patient. The range of adequately illuminatedvisibility in this case does not extend all the way to ostium 1020, asindicated schematically by the rays 1009 shown extending distally fromscope 1008. In this case, adequately illuminated visualization ofguidewire 10 into ostium 1020 would not be possible via scope 1008.Additionally, if sinus guide 1002 is physically capable of beingextended further distally to place the distal end thereof at theapproach to ostium 1020, scope 1008 would also not be capable ofadequately visualizing this. Thus, prior to the current invention,fluoroscopic or other x-ray visualization of these procedures wasrequired, in order to ensure that the devices approach (and extendthrough) the appropriate ostium 1020 and not another adjacent opening,such as opening 1024.

In order to overcome these and other problems, the guidewire devices 10of the present invention include their own light emitting capability. Byilluminating a distal end portion of guidewire 10, a process known astransillumination occurs as guidewire 10 traverses through the sinuspassageways, passes through an ostium and enters a sinus cavity.Transillumination refers to the passing of light through the walls of abody part or organ. Thus, when guidewire 10 is located in a sinus, thelight emitted from guidewire 10 passes through the facial structures andappears as a glowing region on the skin (e.g., face) of the patient. Itis noted that the light emitted from scope 1008, such as positioned inFIG. 3, for example, results in transillumination as well, but theresultant glow is much more diffuse and larger in area. As the lightsource in guidewire 10 gets closer to the surface of the structure thatit is inserted into (e.g., the surface of the sinus), thetransillumination effect becomes brighter and more focused (i.e.,smaller in area). Additionally, the movements of the guidewire 10 can betracked by following the movements of the transillumination spotproduced on the skin of the patient.

FIG. 4 shows an illuminating guidewire 10 according to one embodiment ofthe present invention. Device 10 includes a flexible distal end portion10 d that provides a similar degree of flexibility to a standard,non-illuminating type of guidewire. Distal end portion 10 d may includea coil 10 c as an exterior portion thereof, to help provide the desiredflexibility to this portion. The proximal end portion 10 p of device 10extends the device to provide a sufficient length so that device 10extends proximally out of the patient (and, when inserted throughanother device, such as a sinus guide, proximally out of the device intowhich guidewire 10 is inserted), at all times, including the deepestlocation into which the distal end of device 10 is placed. The proximalend portion 10 p can have visible markings, preferably spaced at equalintervals, that can be observed by the user to confirm how far theguidewire 10 has been placed in the patient. Proximal end portion 10 palso provides the necessary mechanical properties required to make theguidewire function properly. These mechanical properties includetorquability, i.e., the ability to torque the proximal end portion 10 pfrom a location outside of the patient and have that torque transmittedto the distal end portion 10 p; pushability, i.e., sufficient rigidity,so that when an operator pushes on the proximal end portion 10 p from alocation outside of the patient, the pushing force transmits to thedistal portion 10 d to advance the distal portion 10 p without bucklingthe device 10; and tensile strength so that an operator can pull on theproximal end portion 10 p from a location outside of the patient andwithdraw device 10 from the patient without significant plasticdeformation or any disintegration of the device.

Coil 10 c may be formed from a stainless steel wire, for example. Thediameter of the coil wire can be between about 0.004 and about 0.008inches, typically about 0.006 inches. Alternative materials from whichcoil 10 c may be formed include, but are not limited to: ELGILOY®,CONICHROME® or other biocompatible cobalt-chromium-nickel alloy;nickel-titanium alloys, or other known biocompatible metal alloys havingsimilar characteristics. Further alternatively, distal end portion maycomprise a braided metallic construction of any of the aforementionedmaterials in lieu of a coil.

The external casing of the proximal portion lop can be made from apolyimide sheath, a continuous coil (optionally embedded in polymer orhaving polymer laminated thereon), a hypotube (e.g., stainless steelhypotube), a laser-cut hypotube, a cable tube, or a tube made fromPEBAX® (nylon resin) or other medical grade resin. In any of these casesthe construction needs to meet the required torquability, pushabilityand tensile requirements of the device.

In the example shown, coil 10 c is joined to proximal portion 10 p bysolder, epoxy or other adhesive or mechanical joint. One or moreillumination channels 10 i are provided in device 10 and extend thelength thereof.

Illumination channels 10 i are configured to transport light from theproximal end of device 10 to and out of the distal end of device 10. Inthe example shown, two illumination channels are provided, eachcomprising a plastic illumination fiber. The plastic used to make theillumination fibers is compounded for light transmission propertiesaccording to techniques known and available in the art. As one example,ESKA™ (Mitsubishi Rayon), a high performance plastic optical fiber maybe used, which has a concentric double-layer structure with high-puritypolymethyl methacrylate (PMMA) core and a thin layer of speciallyselected transparent fluorine polymer cladding. In one example,illumination fibers each have an outside diameter of about 0.010″. Theillumination fibers can have an outside diameter in the range of about0.005 inches to about 0.010 inches. Alternatively, a single plasticillumination fiber 10 i may be used that has an outside diameter ofabout 0.020″. Further alternatively, glass illumination fibers may besubstituted which are much smaller in outside diameter, e.g., about0.002″. In this case, more illumination fibers may be provided in abundle, e.g., about six to fifty glass fibers 10 i may be provided.

The distal end of device 10 is sealed by a transparent (or translucent)seal 10 s which may be in the form of epoxy or other transparent ortranslucent adhesive or sealing material. Seal 10 s maintains the distalends of illumination fibers 10 i coincident with the distal end ofdevice 10 and also provides an a traumatic tip of the device 10.Further, seal 10 s prevents entrance of foreign materials into thedevice. The distal end can be designed to either focus or distribute thelight as it emanates therefrom, to achieve maximum transilluminationeffects. In this regard, the distal end can include a lens, prism ordiffracting element.

The proximal end of device 10 is also sealed by a transparent (ortranslucent) seal 10 ps which may be in the form of epoxy or othertransparent or translucent adhesive or sealing material. Seal 10 psmaintains the proximal ends of illumination fibers 10 i coincident withthe proximal end of device 10. The proximal end of device 10 maybefurther prepared by grinding and polishing to improve the opticalproperties at the interface of the proximal end of device 10 with alight source. The illumination fibers 10 i at locations intermediate ofthe proximal and distal ends need not be, and typically are not fixed,since no mapping of these fibers is required, as device 10 provides onlyillumination, not a visualization function like that provided by anendoscope. Further, by leaving illumination fibers free to move atlocations between the proximal and distal ends, this increases theoverall flexibility and bendability of device 10 relative to a similararrangement, but where the illumination fibers 10 i are internallyfixed.

The outside diameter of device 10 may be in the range of about 0.025inches to about 0.040 inches, typically about 0.030 to 0.038 inches, andin at least one embodiment, is about 0.035″±0.005″. At least the distalportion Iop of device 10 is provided with a core support 10 cw that iscontained therein. In the example shown in FIG. 4, core support 10 cw isa wire that is fixed to proximal section 10 p such as by laser welding,epoxy or other adhesive or mechanical fixture. Core support 10 cw mayextend substantially the full length of device 10. In any case, coresupport 10 cw is typically formed from stainless steel NITINOL(nickel-titanium alloy) or other biocompatible nickel-titanium alloys,cobalt-chromium alloys, or other metal alloys that are biocompatible andprovide the necessary rigidity and torquability. Core support 10 cw maybe formed as a wire, as in the example shown in FIG. 4, oralternatively, may be braided from any of the same materials orcombination of materials mentioned above. Core support 10 cw, whenformed as a wire can be ground to different diameters to provide varyingamounts of rigidity and torquability. When formed as a braid, the braidcan be formed to have varying amounts of rigidity and torquability alongthe length thereof. For example, core wire 10 cw has a larger outsidediameter at the proximal end portion than at the distal end portion sothat it is more rigid and transfers more torque from the proximalportion of device 10, whereas at the distal end portion, core 10 cw isrelatively more flexible and twistable. For core supports 10 cw thatextend through proximal portion 10 p, the portion of core support nearthe proximal end of device 10 may have an even larger outside diameter.

Core support 10 cw particularly increases the pushability and thetorquability of coil 10 c which, by itself, is quite flexible andtwistable. Combined with the core support 10 cw, the distal portion ismuch more effective at transferring pushing and torquing forces withoutbuckling or twisting. Additionally, core support 10 cw may beplastically deformed or memory set into a bent shape, an example ofwhich is shown in FIG. 5. Bend 10 b provides a steerability function,allowing an operator to direct the distal end of device 10 in differentdirections by torquing device about the longitudinal axis of the device,as indicated by the arrows in FIG. 5. In some embodiments this bendingcan be performed by an operator in the midst of a procedure, which canbe particularly useful in combination with a scope 1008, as viewingthrough the scope may make it apparent to the operator that theguidewire 10 needs to be inserted or directed at an angle offset fromwhere the straight direction along the longitudinal axis of the devicewould direct it to. In some embodiments, the guidewire 10 does not havea core support or core wire. In these embodiments, the outer jacket(e.g., a coil, cable tube, laser-cut hypotube, braided polymer tube,etc.) provides the support for torque, pushability and tension. Anadvantage of not having a core wire/core support is that the full innerdiameter of the guidewire is then available to be filled withillumination fibers.

The illumination fibers, as noted above, can be free to move aboutradially within the device. Further, there is no need to center theillumination fibers 10 i with respect to device 10 even at the distaland proximal ends of the device. FIG. 6 is a sectional illustration of adistal end portion of device 10 showing core support 10 cw fixed to coil10 c, with illumination fibers 10 i residing adjacent to core support 10cw, but not fixed to either core support 10 cw or coil 10 c.

The plastic or glass illumination fibers 10 i of the device shown inFIG. 4 are typically used to transmit light from a light source such asone provided in a operating room for use by endoscopes, e.g., xenonlight source, halogen light source, metal halide light source, etc.Alternatively, device 10 may be configured to transmit light from otherlight sources, such as a laser light source, wherein laser fibers 10 fwould be substituted for the illumination fibers described above, andextend through device 10 in a fiber optic bundle as illustrated in thecross-sectional view of FIG. 7. The fiber optic bundle, like theillumination fibers 10 i, contributes to stiffness (in both bending andtorquing motions) of device 10, thereby enhancing trackability, steeringand other torquing.

FIG. 8 illustrates another embodiment of an illuminating guidewire 10.In this example, proximal end portion of device 10 is formed externallyby a coil with a polymer layer laminated thereon, but any of the otherarrangements described above may be substituted. In this example,illumination is provided by a high intensity light emitting diode (LED)10 id fitted at the distal end of device 10. The proximal end of device10 may be sealed such as with epoxy, or any of the other alternativesmentioned above with regard to the proximal end of device 10 in FIG. 4,in order to prevent pulling on the wires 10 iw at the connections withLED 10 id, as well as to seal the proximal end of the device. Grindingand polishing are not necessary, as the proximal end of device 10 inFIG. 8 does not transmit light.

Device 10 in FIG. 8 performs substantially similar to the device 10 ofFIG. 4 with regard to the properties of pushability, torquability andtensile properties. Device 10 of FIG. 8, however, does not requireillumination fibers or laser fibers. Instead, a pair of insulated leadwires are electrically connected to the terminals of LED 10 id (notshown) and then extend within device 10 over the length of device 10 toextend proximally from the proximal end of device 10. The free ends ofwires 10 w are configured to be connected to a power source thatfunctions as the source of electrical power, to deliver electricalenergy to LED 10 id to illuminate it. FIG. 9 illustrates across-sectional view of a distal end portion of device 10 of FIG. 8. Inthis example, core support 10 cw is in the form of a flattened distalend core wire or shaping ribbon as known in the art, that extendsbetween the two wires 10 w. FIG. 9 also illustrates the insulation layer10 iw over each wire.

Any of the devices 10 described herein may optionally include one ormore radiopaque markers and/or electromagnetic coils on the tip of thedevice 10 and/or elsewhere along the device for enhancing visibility byfluoroscopy systems, image guided surgery (IGS) systems, or othervisualization systems.

FIG. 10 shows an alternative design of device 10 in which light isemitted proximally of the distal end of the device. This configurationmay employ any of the various light transmission means described above(e.g., illumination fibers, laser fibers, LED). The proximal portion 10p may be constructed in any of the manners described above with regardto other embodiments of device 10. The distal portion 10 d includes atransparent proximal end portion 10 dp that mounts over the distal endof proximal end portion 10 p of the device 10. The transparent portion10 dp permits the illumination emitted from illumination member 10 i or10 id to pass out of the device 10 at the location of transparentportion 10 dp. The illumination member(s) 10 i or 10 id thus terminateat the proximal end portion 10 dp of the distal end portion of device10. Distally of this transparent portion 10 dp, the distal portion 10 ddof distal end portion 10 d of device 10 extends as a floppy guidewireleader or tip. This floppy guidewire leader or tip 10 dd may include acoiled section 10 c and may optionally include a core support 10 cw inthe manner described above with regard to FIG. 4. The light emitted fromillumination fibers will disperse naturally through the transparentportion 10 dp. Optionally, a deflector 11, such as a convex mirror(e.g., parabolic or other convex) shape or other reflective surface maybe provided distally of illumination fibers/light emitting portion 10 i,10 id of device 10 to deflect light rays out of the transparent portion.Additionally, or further alternatively, illumination fibers 10 i may beangled at the distal end portions thereof to direct the emitted lightout through the transparent portion.

This configuration may be beneficial in further protecting theillumination emitter(s) 10 i, 10 id from foreign materials inside thebody, as well as from trauma that may be induced by bumping theillumination emitter up against structures within the body. Further, afloppy guidewire leader 10 dd of this type may provide more flexibilityand maneuverability than a device in which the illumination emitter islocated on the distal tip of the device.

Transparent portion 10 dp may be provided as a clear plastic or glassintegral tube, or may have openings or windows 10 t provided therein(see the partial view of FIG. 10). Further alternatively, transparentportion may be formed by a plurality of struts 10 st circumferentiallyarranged to interconnect the distal floppy tip 10 dd with the proximalend portion 10 p of device 10 as shown in the partial illustration ofFIG. 12. Alternatively members 10 st may be intersecting in acriss-crossing cage like configuration or other cage configuration. Inany of these alternative configurations, members 10 st may betransparent, but need not be and could be formed of non-transparentmaterials, such as metals or opaque plastics, for example.

Device 10 should be readily connectable to and disconnectable from apower source to enable attachment for providing illumination forpositioning the guidewire 10 and/or other devices during a procedure,detachment to allow another device to be slid onto the guidewire 10 froma free proximal end thereof, and reattachment to again provideillumination, to assist in guidance/visualization of the device beingpassed over the guidewire 10, for example.

FIGS. 13A and 13B illustrate one example of a coupler 20 that isconfigured for quick connection and disconnection of an illuminationguidewire 10 that employs illumination fibers 10 i or laser fibers 10 f.Coupler 20 is connected to a light source 1030, such as a conventionalendoscope light source, for example, or other light source capable ofdelivering preferably at least 10,000 lux through coupler 20. Lightcable 1032 optically connects connector 20 with light source 1030 todeliver light from the light source 1030 to connector 20. Light cable1032 can optionally be a fluid-filled light cable, such as the typeprovided with DYMAX BlueWave™ 200 and ADAC Systems Cure Spot™ lightcables, for example. A liquid filled light cable comprises a lightconducting liquid core within plastic tubing. The liquid is non-toxic,non-flammable and transparent from 270 to 720 nm. The ends of a liquidfilled light cable can be sealed with high quality quartz glass andmetal spiral tubing surrounded by a plastic sleeve for exteriorprotection.

Connector 20 includes a proximal channel, slot or bore 22 that has aninside dimension or circumference that is slightly greater than theoutside diameter or circumference of device 10 at the proximal endportion 10 p. A quick release locking mechanism 24 is provided forlocking and unlocking device 10 within connector 20. Quick releaselocking mechanism is biased toward the locking position shown in FIG.13B, in which the locking portion 24 a of mechanism 24 is driven intochannel slot or bore 22 and may even abut against the opposite wall ofthe channel, slot or bore 22, when no guidewire 10 has been inserted.Locking mechanism 24 may be spring-biased toward the locked position,for example. Additionally, locking mechanism 24 may include a ball anddetent arrangement, or other temporary locking means to maintain themechanism 24 in the locked configuration. An additional, similarmechanism may be provided to temporarily fix locking mechanism 24 in theunlocked configuration shown in FIG. 13A. Alternative locking mechanismsmay be employed, such as a pivoting lock arm, for example, that ismanually pivotable between the locked and unlocked orientations, orother mechanism that would be apparent to one of ordinary skill in themechanical arts, such as a collapsible silicone valve that grips thedevice, for example.

Light cable 1032 generally has a much larger inside diameter than theinside diameter or combined inside diameters of the illumination fibers10 i. Accordingly, the proximal end portion of connector 20 provides atapering or funnel shaped pathway 26 having a proximal inside diameterthat is substantially equivalent to the inside diameter of cable 1032 orgreater, and which tapers to a distal inside diameter that is about thesame or only slightly greater than the inside diameter or combinedinside diameters of the illumination fiber(s), or alternatively, that isabout the same or only slightly greater than the outside diameter of theproximal end of device 10. The light cable 1032 generally has a largerdiameter bundle of illumination fibers than that contained within theilluminating guidewire 10. Accordingly, the tape 26 is used totransition between the larger bundle in the light cable 1032 and thesmaller bundle in the guidewire 10. With this arrangement, lightdelivered through light cable 1032 is concentrated or focused down to apathway where most of the light can be transmitted through theillumination fibers.

To insert device 10 into connector 20, an operator retracts quickconnect locking mechanism 24 to the open position shown in FIG. 13A. Ifquick connect mechanism 24 is provided with a temporary lockingmechanism as referred to above, then quick connect locking mechanism 24can be temporarily fixed in the orientation shown in FIG. 13A, withoutthe operator having to hold it open. Otherwise, the operator will holdconnector 24 open in the position shown in FIG. 13A. The proximal end ofdevice 10 is next inserted into the open channel, slot or bore 22 andslid proximally with respect to connector 20 until the proximal end ofdevice 10 abuts against the proximal end of channel, slot or bore 22.Quick release mechanism is next released by the operator (in embodimentswhen there is no temporary locking mechanism to maintain the quickrelease in the open configuration) or released from the temporary lockedopen configuration, so that the locking arm 24 a is advanced toward theproximal end portion 10 p of device 10, by the biasing of quick connectlocking mechanism 24 described above. Locking arm 24 a contacts device10 and holds device 10 under compression between locking arm 24 a andthe opposite inner wall of channel, slot or bore 22, with sufficientforce to prevent device 10 from sliding out of connector 20 even if thedistal tip of device 10 is pointed straight down in a verticaldirection. Optionally, locking arm 24 a may be additionally temporarilylocked in place by a ball and detent mechanism, or other temporarylocking mechanism, as mentioned above. To remove device 10 fromconnector 20, quick connect locking mechanism 24 is repositioned to theopen or unlocked orientation shown in FIG. 13A and the device is sliddistally with respect to the connector until it is free from theconnector 20.

FIGS. 14A-14B illustrate an alternative connector 20 that includes aquick release locking mechanism 24. In this example, two or more lockingarms 24 are provided circumferentially about the distal end of connector20. Arms 24 are biased to the closed or locked configuration as shown inFIG. 14A. For example, arms 24 may be made from resilient spring steel,nickel-titanium alloy or resilient plastic and formed to assume theconfiguration shown in 14A when mounted to connector 20 and when in anunbiased state. Installation of device 10 into connector 20 issimplified by the automatic grasping and temporary locking functionsprovided by quick release locking mechanism 24. The proximal end ofdevice 10 is simply inserted between the two or more arms 24. Arms 24included ramped or cammed surfaces 24 b that guide the proximal end ofdevice 10 into connector 20, and, as device 10 is pushed against thesesurfaces 24 b, arms 24 are deflected into the opened, biasedconfiguration shown in FIG. 14B. The biasing/resiliency of arms 24imparts compressive forces to the shaft of device 10 via temporarylocking surfaces 24 a, so that device 10 is gripped and held in positionas shown in FIG. 14B. To remove device 10, the operator needed simplypull on device 10, while holding connector 20 relatively immobile, witha force sufficient to overcome the compressive and frictional forcesimparted by surfaces 24 a. The resilient arms 24 then return to theunbiased configuration shown in FIG. 14A. Optionally, surfaces 24 a maybe coated with, or include a friction enhancing surface, such as rubberor other elastomer, and/or be roughened, such as by knurling or othersurface roughening technique.

In the example shown in FIGS. 14A-14B, the light cable 1032 that isprovided has an inside diameter that is about the same as the diameterof the proximal end of device 10 and thus, no tapering channel 26 isrequired. However, for arrangements where the light cable 1032 is muchlarger, as is usually the case when using a conventional endoscope lightsource 1030, connector 20 may be provided with a tapering light channel26 in the same manner as described above with regard to the embodimentof FIGS. 13A-13B.

FIG. 15 illustrates a longitudinal sectional view of a connector 20 thatis quickly connectable and releasable from a guidewire device 10 and isalso connectable to and releasable from standard light source cablesthat are typically found in operating rooms. Thus, this connector 20functions both as an adapter to connect to a conventional endoscopelight source channel or cable, and as a quick release locking connectorto connect to and release from a proximal end portion of guidewire 10.

The proximal end of connector 20 is provided with a light post 28 thatis configured to mate with a connector on the distal end of a lightcable extending from a conventional endoscope light source. For example,light post 28 may be an ACMI light post (ACMI Corporation) or otherstandard connector typically used to connect endoscopes to operatingroom light sources. Because the cable extending from an operating roomlight source generally has a much larger inside diameter than the insidediameter or combined inside diameters of the illumination fibers ofdevice 10, and larger than the diameter of the proximal end of guidewire10, the proximal end portion of connector 20 includes a light taperingor funnel-shaped pathway 26 like that described above with regard toFIG. 13A.

The quick release locking mechanism 24 in this example includes a collet24 c that is configured to center the proximal end of device 10 with thedistal end of tapering pathway 26. A threaded cap 24 d is threaded overmating threads 24 t on the body of connector 20, so that when cap 24 dis torqued in a direction to advance cap 24 d proximally with respect tothe body of connector 20, inner ramped or cammed surfaces 24 e of cap 24d ride over outer ramped or cammed surfaces 24 f of collet 24 c, therebyfunctioning as a pin vise and clamping collet 24 c against the proximalend portion of device 10 to clamp and maintain device 10 in its currentposition relative to connector 20. To insert device 10, cap 24 d isrotated in a reverse direction from that described above to open thedistal opening of the inner channel 24 g of collet 24 c to a dimensionlarger than the outside diameter of the proximal end of device 10, sothat device 10 can be easily slid through the channel 24 g until theproximal end of device 10 abuts the proximal end portion of collet 24 c,or approximates the same. The cap 24 d is then turned with respect tothe body of connector 20 to clamp device 10 into position, as describedabove. Removal of device 10 can be performed by turning cap 24 d in areverse direction relative to connector body 20, thereby loosening thegrip of collet 24 c on device 10, after which device 10 can be easilyslid out from connection with connector 20. Components of connector 20may be made from metal, such as stainless steel or other biocompatiblemetals, or temperature-resistant thermosetting polymer, for example.

Light post 28 is rotatable with respect to the light cable 1032 of thelight source 130 when connector 20 is connected to the distal endconnector of the light cable 1032. This allows device 10, when connectedto connector 20 in this arrangement, to be rotated during use withoutbuilding up significant twisting or rotational counter forces within thelight cable 1032. For example, in the light post 28 shown, the femalereceptacle (not shown) of the light cable 1032 couples over light post28 and engages in groove 28 g, about which the female receptacle is thenrotatable relative to light post 28. FIG. 16 is a longitudinal sectionalview of a connector 20 that is similar to the connector 20 describedwith regard to FIG. 15 above. One difference in the example of FIG. 16is that the tapered light guide 26 is provided in the light post 28, ascontrasted with being provided in the proximal end portion of the mainbody of connector 20 in FIG. 15. However, in both cases, the function isthe same.

Turning now to FIGS. 17A-17E, illustrations of partial coronal sectionalviews through a human head showing various steps of a method fortreating an ostium that opens to a frontal sinus are shown. The methodsdescribed here, and all other methods disclosed herein may also comprisea step of cleaning or lavaging anatomy within the nose, paranasal sinus,nasopharynx or nearby structures including but not limited to irrigatingand suctioning. The step of cleaning the target anatomy can be performedbefore or after a diagnostic or therapeutic procedure. The methods ofthe present invention may also include one or more preparatory steps forpreparing the nose, paranasal sinus, nasopharynx or nearby structuresfor the procedure, such as spraying or lavaging with a vasoconstrictingagent (e.g., 0.025-0.5% phenylephyrine or Oxymetazoline hydrochloride(Neosynephrine or Afrin) to cause shrinkage of the nasal tissues, anantibacterial agent (e.g., provodine iodine (Betadine), etc. to cleansethe tissues, etc.

In FIG. 17A, a first introducing device in the form of a sinus guide1002 is introduced through a nostril and through a nasal cavity 1012 toa location close to an ostium 1034 of a frontal sinus 1036. Sinus guide1002 may be as described previously herein, or as described in theapplications incorporated herein by reference. The advancement of sinusguide 1002 can be visualized with a scope inserted into the nasal cavity1012 and advanced as close to the ostium 1034 as possible withoutcausing significant trauma to the tissues therein.

Once the surgeon is satisfied that the distal end of the sinus guide1002 is positioned close enough to the appropriate ostium 1034,illuminating guidewire 10, connected to a light source as described byany of the techniques mentioned above, is inserted through sinus guide1002 and advanced therethrough, see FIG. 17B. There may be sometransillumination from the light emitted from the scope which can beused to confirm that the sinus guide 1002 is positioned in the correctgeneral area, which confirmation can be made even before the distal tipof guidewire 10 exits the distal end of sinus guide 1002. However, muchmore specific transillumination effects are produced when the tip ofguidewire 10 exits the distal end of guide 1002 and especially when thelight emitting portion of guidewire 10 touches or approximates anintended target surface, such as an inner wall of a sinus, for example.As the guidewire 10 is advanced, transillumination on the face of thepatient can be observed as a glowing spot that moves as the distal endportion of device 10 moves, thereby making it possible to visibly trackthe location of the light emitting portion of device 10 without the needto use radiographic imaging, such as by fluoroscopy, for example.

While there may be some diffuse transillumination on the forehead of thepatient overlying the frontal sinus 1036 as the light emitting portionof device 10 approaches the ostium 1034, the glow on the foreheadbecomes brighter and smaller in dimension (more focused) as the lightemitting portion passes through the ostium 1034 and enters the frontalsinus 1036, FIG. 17C. As device 10 is further advanced, the glowing spotbecomes most defined and brightest as the light emitting portionapproaches and contacts a wall of the frontal sinus 1036. Further, asnoted, the movement of the transilluminated spot can be visibly followedto confirm that the guidewire 10 is indeed moving within the location ofthe frontal sinus, as can be confirmed by the surgeon's knowledge of theparticular anatomy of the patient being treated. In this regard, a CATscan or other image of the sinus anatomy can be performed prior to thisprocedure and studied by the surgeon, to apprise the surgeon of anydistinctive or unusual patterns in the individual patient's sinusanatomy which might be useful in tracking and confirmation of where theguidewire is located, as indicated by the transillumination.

Once properly positioned, the proximal end of device 10 is disconnectedfrom connector 20, while leaving guidewire 10 in its current position. Aworking device 1006, for example a balloon catheter, is the introducedover guidewire 10 and advanced thereover so that the proximal end ofdevice 10 extends proximally beyond a proximal end of device 1006.Device 10 is then reconnected to connector 20 so that light is againemitted from the light emission portion of the distal end portion ofdevice 10. Thus it can be visually confirmed, without radiography, thatthe distal end portion of the guidewire 10 remains properly in thefrontal sinus 1036 as the working device 1006 is advanced toward ostium1034 and the balloon of working device 1006 is extended across theostium, FIG. 17D. The proper positioning of the working end (distal endportion) of working device 1006 can be visualized with the scope and/orfluoroscopy.

Once proper placement of the working device 1006 has been confirmed,working device 1006 is used to perform a diagnostic or therapeuticprocedure. In this particular example, the procedure is dilatation ofthe frontal sinus ostium 1034 by expansion of the balloon thereagainst,to enlarge the opening of the ostium 1034. However, it will beappreciated that the present invention may also be used to dilate ormodify any sinus ostium or other man-made or naturally occurringanatomical opening or passageway within the nose, paranasal sinuses,nasopharynx or adjacent areas. Further, other working tools may beinserted and used according to these same techniques. After thecompletion of the procedure, sinus guide 1002, guidewire 10 and workingdevice 1006 are withdrawn and removed, completing the procedure, seeFIG. 17E.

Illuminating guidewire device 10 can also be used to facilitatevisualization and placement of the sinus guide 1002 in the proceduredescribed above with regard to FIGS. 17A-I7E, or in another procedure inwhich a sinus guide, guide catheter or guide tube is placed in the sinuspathways. FIG. 18 illustrates a situation, like that described abovewith regard to FIG. 3, where scope 1008 has been inserted as far aspossible without causing significant trauma to the patient. The range ofvisibility in this case does not extend all the way to ostium 1034, asindicated schematically by the rays 1009 shown extending distally fromscope 1008. In this case, adequate visualization of sinus guide 1002 byscope 1008 is possible only up to the extent of the rays 1009 shown.Thus, if sinus guide 1002 is flexible enough to be advanced more closelyto ostium 1034, then adequate visualization of this movement would notbe possible via scope 1008. That is, if sinus guide 1002 is physicallycapable of being extended further distally to place the distal endthereof at the approach to ostium 1034, scope 1008 would not be capableof adequately visualizing this. However, by inserting illuminatingguidewire through sinus guide 1002 as shown in FIG. 18, additionallyillumination can be provided distally of the illuminating range of scope1008. This additional illumination can be received by scope 1008 toenable visualization up to the illumination portion of device 10 andpotentially even extending to illumination range of device 10, as longas there is a straight pathway of the field of view. Thus, advancementof the sinus guide 1002 can be visualized further distally by the scope1008 using this technique, and potentially all the way up to the ostium1034.

Additionally, this technique can be used to visualize placement of theguidewire 10 up to and into the desired ostium 1034. Alternatively, thiscan be carried out without the sinus guide 1002, wherein the guidewire10 is inserted and the scope 1008 can be used to visualize placement ofguidewire 10 into the target ostium with the assistance of the lightemitted by the scope 1008 in addition to the light emitted by guidewire10.

In any of these procedures where a scope 1008 is used for visualizationand an illuminating guidewire is inserted, some transillumination of thetarget sinus may occur from the light emitted by the scope 1008 alone.However, this transillumination will be diffuse and show a rather dim,large area of transillumination on the patient's skin. When theillumination guidewire is inserted and advanced, as noted earlier, asmaller, brighter transillumination spot will be visible when theilluminating portion of the guidewire has entered the sinus.Additionally, even before entering the sinus, the light emitted from theguidewire will produce a moving transillumination spot at guidewire 10is advance, which also helps distinguish the location of the distalportion of the guidewire, relative to any diffuse transilluminationproduced by the scope light.

If the guidewire 10 is advanced into an ostium other than the targetostium (e.g., ostium 1035 shown in FIG. 18), this may be possible to beviewed by scope 1008, depending upon the line of sight. However, even ifit is not, the transillumination resulting from entrance into adifferent sinus than the target sinus will be evident by the differentlocation on the patient's face. Also, in the example shown, guidewire 10would not be able to be advanced very far through ostium 135 before itwas diverted and curled by the relatively small sinus space that ostium135 leads into. Thus, by tracking the movement of the illumination spotproduced by guidewire 10, the surgeon could confirm that guidewire 10was misplaced as the guidewire would be diverted by a much smaller spacethen that characterized by the target frontal sinus 1036.

Thus, by using an illuminating guidewire device 10 in the methods asdescribed above, the use of fluoroscopy or other X-ray visualization canbe reduced is not required to confirm proper placement of the guidewirein some cases.

Similar procedures may be carried out in other sinuses. For example, asimilar procedure to that described above with regard to FIGS. 17A-17Emay be carried out to open or expand an opening of an ostium leading toa maxillary sinus. In this case, when illuminating guidewire device 10passes through the ostium that opens to the target maxillary sinus andenters the maxillary sinus, a relatively bright, relatively small,defined transillumination spot can be observed to move across the cheekregion of the patient. As guidewire 10 is advance further distally alongthe maxillary sinus, the maxillary sinus typically tends to track in aninferior direction relative to the skull, and the bottom wall of themaxillary sinus is very close to the palate of the patient. Therefore asthe illuminating portion of guidewire approaches and/or touches thebottom wall of the maxillary sinus, a transillumination spot can beobserved on the roof o the patient's mouth by looking into the mouth ofthe patient. At the same time, the transillumination spot on the cheekthat was caused by the guidewire will diminish, or not be visible at allat this time. This viewability on the roof of the mouth is furtherconfirmation that the guidewire has entered the maxillary sinus.Movement of the transillumination spot on the roof of the mouth can alsobe observed as the guidewire 10 is advanced and/or retracted.

It is further noted that some wavelengths of light may be more effectivein producing the transillumination effects described herein, for thepurpose of locating the position of the guidewire. In this regard,particular wavelengths of visible light can be selected for thispurpose. Alternatively, or in addition, infrared wavelengths may beparticularly effective. In this regard, guidewires that employilluminating fibers may be provided with a filter 12 to define thecolor/wavelength of the light emitted by device 10. As schematicallyshown in FIG. 19, filter 12 may be provided distally of the illuminationfibers, such as at the distal tip of device 10, proximally of theillumination fibers, such as at the proximal end of device 10, or in thelight pathway at a location within connector 20, for example. Multiplefilters may be placed at one or more of these locations. For devices 10that employ an LED light emitting component, different color LEDs may beemployed to emit different wavelengths of light. For devices 10 thatemploy laser fibers, different types of lasers may be used that emitdifferent wavelengths of light.

Another optional feature that guidewire 10 may be provided with is theability to emit strobed, flashing or flickering light. Thetransillumination produced by a flashing light can be furtherdistinguished from diffuse transillumination produced by other lightsources, such as endoscopes, for example, since the transilluminationproduced by the guidewire 10 in this case will flicker or vary inintensity between bright and dim. To produce this type of light, eithera light source having strobing capability could be connected to thedevice 10, or connector 20 may be provided with this capability. Whenusing a laser light source or an LED as the light emitter, as describedin embodiments above, a blinking or strobing effect can beelectronically generated according to techniques known in theelectronics and lighting arts. FIG. 20A schematically illustrates aconnector 20 having a rotating shutter 27 rotatably mounted therein sothat the vanes 27 v and gaps 27 g between the vanes (see plane view inFIG. 20B) become successively aligned with the light pathway through theconnector 20 to alternate emission and blocking of light transmissionout of the connector 20 and ultimately through device 10 when a device10 is connected thereto. Shutter 27 can be powered by a motor 29 that iseither battery powered or connectable to an operating room power source,and motor can be operated by the user via actuator 31, which can beconfigured to turn the motor on and off, and optionally can beconfigured to vary the speed of rotation. Alternatively, shutter can beconfigured so that vanes 27 v extend through a slot in connector 20whereby a user can manually rotate the shutter to cause the lightemitted from device 10 to flicker.

Other instruments that are designed to be inserted into a sinus, or atleast to be positioned at the ostium of a sinus can also be providedwith illumination capability according to any or all of the featuresdescribed above with regard to illumination guidewires. FIG. 21 shows afrontal ostium seeker 100 instrument that can be used to access a sinusostium. For example, seeker 100 may be provided with a length of about175mm to about 250 mm ( about 208 mm in the example shown) and a balltip at one or both ends of the instrument. In FIG. 21, seeker 100 isalso provided with a light emitter 104 at one or both ends of the device100 that can be used to locate an end of device 100 as it is beingadvanced to seek an ostium, by the transillumination effects asdiscussed above. Light emitters 104 may be provided by LED, lightillumination fibers or laser illumination fibers, for example. One orboth end portions of the instrument may include a light fiber bundle orelectrical wires for connection to a light source or power source in amanner as described above.

FIG. 22 shows a suction sinus instrument 110 that is configured toevacuate blood and/or other fluids from a target surgical site, such asthe frontal sinus, sphenoid sinus or other sinus, to improve visibilityof a surgical procedure. Instrument 110 includes an elongated shaft 116with a distal end that opens to deliver suction via a suction lumen end112. Additionally, a light emitter 114 is provided at the distal end ofshaft 116, which may be an LED or one or more illumination fibersconfigured to transmit light in a manner as described above. Shaft 116is configured and dimensioned to be inserted into the sinus passagewaysand sinuses. The proximal end portion of instrument 110 may include alight fiber bundle 118 or electrical wires for connection to a lightsource or power source in a manner as described above.

FIG. 23 shows an integrated wire dilatation catheter 120 that includesan elongate, flexible catheter shaft 126 having a balloon 128 mountedthereon. A proximal Luer hub 122 is attached to the proximal end of thecatheter shaft 126. An inflation device (not shown) may be attached tothe Luer hub 122 and used to inflate and deflate the balloon 128. Anon-removable, integrated guide member 124 extends out of and beyond thedistal end of the catheter shaft 126. Guide member 124 can extendthrough the length of catheter shaft 126 and extend proximally thereofas shown in FIG. 23. The proximal end portion may be configured with apolished proximal end containing illumination fibers, as describedpreviously, or may have one or more electrical wires extendingproximally thereof for connection with an electrical power source todeliver electrical power to an LED, for example. A light emitter 125 maybe provided at the distal tip of integrated guide member 124, as shownin FIG. 23 and may be one or more LEDs or one or more illuminationfibers, according to any of the different embodiments described above.Alternatively, light emitter 125 may be provided proximally of thedistal tip of guide member 124, in a manner like that described withregard to FIG. 10, for example. Further alternatively, guide member maynot extend through the entire length of catheter 126 or may not extendproximally of balloon member 128 at all. In these examples, lightemitter may be an LED, wherein wires can be threaded through oralongside of catheter 126 and into guide member 124 to connect with theLED. Further alternatively, if light emitter 125 comprises one or moreillumination fibers, the illumination fibers may extend proximally ofthe proximal end of the guide member 124, and proximally throughcatheter 126 where they are not surrounded by an external sheath in aguidewire formation.

In one preferred embodiment for adult applications, balloon catheter 120has an overall length of approximately 43.5 cm and its shaft 126 has anouter diameter of about 0.058 inches. Further details about integratedwire dilatation catheters that may be configured with a light emitter ina manner as described herein can be found in co-pending Application Ser.No. 11/438,090 filed May 18, 2006 and titled “Catheters withNon-Removable Guide Members Useable for Treatment of Sinusitis.Application Ser. No. 11/438,090 is hereby incorporated herein, in itsentirety, by reference thereto.

While the present invention has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of theinvention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentinvention. All such modifications are intended to be within the scope ofthe claims appended hereto.

1-99. (canceled)
 100. An illuminating guidewire device comprising: aguidewire including an elongated main body having a flexible distal endportion; at least one light conducting channel extending the length ofsaid elongated body, said at least one light conducting channel beingconfigured and dimensioned to deliver light from a proximal end of saidguidewire to a distal end of said guidewire and to emit light from saiddistal end.
 101. The illuminating guidewire device of claim 100, whereinsaid at least one light conducting channel comprises at least oneillumination fiber.
 102. The illuminating guidewire device of claim 100,wherein said at least one light conducting channel comprises at leasttwo illumination fibers.
 103. The illuminating guidewire device of claim102, wherein said at least two illumination fibers are formed ofplastic.
 104. The illuminating guidewire device of claim 101, whereinsaid at least one illumination fiber is formed of plastic.
 105. Theilluminating guidewire device of claim 101, wherein each said at leastone illumination fiber is formed of glass.
 106. The illuminatingguidewire device of claim 100, wherein said at least one lightconducting channel comprises at least one laser fiber.
 107. Theilluminating guidewire device of claim 100, further comprising a quickrelease connector mounted over at least part of said proximal endportion of said elongated body, said quick release connector adapted tobe connected to a light channel extending from a light source; and toquickly connect to and release from said proximal end portion of saidelongated body.
 108. The illuminating guidewire device of claim 107,wherein said quick release connector is optically coupled with the lightsource.
 109. The illuminating guidewire device of claim 107, wherein aproximal end portion of said connector comprises a tapering lightchannel configured to adapt a relatively larger inside diameter of thelight channel to a relatively smaller diameter of the proximal end ofsaid elongated body.
 110. The illuminating guidewire device of claim107, wherein a proximal end portion of said quick release connector isadapted to connect with a light source.
 111. The illuminating guidewiredevice of claim 110, wherein said proximal end portion of said quickrelease connector comprises an ACMI light post.
 112. The illuminatingguidewire device of claim 106, wherein said connector is rotatable withrespect to the light channel extending from the light source, when saidconnector is connected to the light channel.
 113. The illuminatingguidewire device of claim 106, wherein a distal end portion of saidconnector comprises an opening configured to slidably receive saidproximal end portion of said elongated body; and a quick release lockingmechanism configured to fix said proximal end portion received in saidconnector.
 114. The illuminating guidewire device of claim 113, whereinsaid quick release locking mechanism in a locked configuration,maintains a proximal end of said elongated body in alignment with adistal end of said tapering light channel.
 115. The illuminatingguidewire device of claim 113, wherein said quick release lockingmechanism is movable between an unlocked configuration in which theproximal end portion can be slid from said connector to disconnecttherefrom, and a locked configuration that maintains said proximal endportion in connection with said connector.
 116. The illuminatingguidewire device of claim 100, further comprising a core supportextending at least within said distal end portion.
 117. The illuminatingguidewire device of claim 116, wherein said core support further extendswithin said proximal end portion.
 118. The illuminating guidewire deviceof claim 100, further comprising a radiopaque marker on said distal endportion.
 119. The illuminating guidewire device of claim 100, furthercomprising an electromagnetic coil on said distal end portion. 120-150.(canceled)
 151. A method for visually confirming the positioning of adistal end portion of a device placed within a patient, said methodcomprising the steps of: inserting a distal end portion of anilluminating device internally into a patient, emitting light from thedistal end portion of the illuminating device; observingtransillumination resulting from the light emitted from the distal endportion of the illuminating device that occurs on an external surface ofthe patient; and correlating the location of the observedtransillumination on the external surface of the patient with aninternal location of the patient that underlies the location of observedtransillumination, to confirm positioning of the distal end portion ofthe illuminating device.
 152. The method of claim 151, wherein saidilluminating device comprises an illuminating guidewire.
 153. The methodof claim 151, wherein said illuminating device comprises an ostiumseeker device.
 154. The method of claim 151, wherein said illuminatingdevice comprises a sinus suction instrument.
 155. The method of claim151, wherein said illuminating device comprises an integrated wiredilatation catheter, wherein an integrated illuminating guidewireextends distally of a distal end of a dilatation catheter of saidintegrated wire dilatation catheter.
 156. The method of claim 151,wherein said observing is performed by direct line of sight humanobservation, without the need for fluoroscopy.
 157. The method of claim151, wherein said observing is performed by direct line of sight humanobservation, without the need for any visualization equipment.
 158. Themethod of claim 151, wherein the distal end portion is inserted into asinus passageway of the patient.
 159. The method of claim 151, whereinthe distal end portion is inserted through an ostium of a sinus of thepatient, and the distal end portion is advanced into the sinus.
 160. Themethod of claim 151, wherein the distal end portion is initiallyinserted through a nostril of the patient and then advanced into asinus.
 161. The method of claim 160, further comprising inserting ascope through the nostril of the patient, wherein the illuminatingdevice is inserted adjacent the scope, and visualizing advancement ofthe distal end portion of the illuminating device via the scope as thedistal end portion is advanced toward an ostium of the sinus.
 162. Themethod of claim 161, wherein said illuminating device comprises anilluminating guidewire.
 163. The method of claim 161, wherein saidobserving transillumination comprises observing transillumination when alight emitting portion of the distal end portion is located in thesinus.
 164. The method of claim 151, wherein said observingtransillumination and correlating steps comprise observing thetransillumination when the distal end portion is misrouted to a locationother than a target location, and said correlating confirms themisrouted location, said method further comprising retracting the distalend portion of the device and re-routing the distal end portion to thetarget location, whereby location of the distal end portion of thedevice in the target location is then confirmed by repeating saidobserving transillumination and said correlating.
 165. The method ofclaim 151, further comprising observing motion of the transilluminationresulting from the light emitted from the distal end portion of theilluminating device, as the distal end portion is moved relative to thepatient; thereby confirming that the transillumination in motioncorrelates to a position of the distal end portion.
 166. The method ofclaim 161, further comprising observing motion of the transilluminationresulting from the light emitted from the distal end portion of theilluminating device, as the distal end portion is moved relative to thepatient, to distinguish the transillumination resulting from the lightemitted from the distal end portion of the illuminating device fromtransillumination resulting from light emitted from the scope.
 167. Themethod of claim 161, further comprising distinguishing thetransillumination resulting from the light emitted from the distal endportion of the illuminating device from transillumination resulting fromlight emitted from the scope by identifying a transillumination spotthat is at least one of brighter, smaller or more well-defined thanother transillumination effects observed.
 168. The method of claim 151,further comprising inserting a guide within the patient prior toinserting the illuminating device, and wherein the distal end portion ofthe illuminating device is inserted through the guide.
 169. The methodof claim 151, wherein the illuminating device is preloaded in a guide,said method comprising inserting the guide and preloaded illuminatingdevice within the patient.
 170. The method of claim 169, furthercomprising advancing the illuminating device relative to the guide toextend a distal end portion of the illuminating device distally out of adistal end of the guide.
 171. The method of claim 169, wherein saidilluminating device comprises an illuminating guidewire.
 172. The methodof claim 168, further comprising inserting a scope within the patient,wherein the guide is inserted adjacent the scope, and visualizingadvancement of the guide via the scope.
 173. The method of claim 172,comprising visualizing advancement of the guide to a limit of adequateillumination of the scope, then advancing the distal end portion of theilluminating device distally of a distal end of the guide and distal ofthe limit of adequate illumination of the scope to emit illumination,thereby extending a length of the adequate illumination of the scope.174. The method of claim 173, further comprising advancing the guidefurther distally under visualization by the scope as facilitated by theextended length of the adequate illumination.
 175. The method of claim173, comprising visualizing advancement of the illuminating devicedistally of the guide via the scope, as facilitated by the light emittedfrom the distal end portion of
 176. The method of claim 172, wherein thescope is inserted into a nostril of the patient, and the guide isinserted adjacent the scope.
 177. The method of claim 176, wherein thescope and guide are advanced into a sinus passageway of the patient.178. The method of claim 177, wherein the guide is further advancedtoward an ostium of a sinus, the advancement of the guide being visuallyobserved via the scope.
 179. The method of claim 175, wherein the scopeis inserted into a nostril of the patient, and the guide is insertedadjacent the scope, and wherein advancement of the guide into a sinuspassageway is visualized via the scope until a distal end of the guidehas reached a distal limit of illumination emitted by the scope. 180.The method of claim 179, wherein further advancement of the guide towardan ostium of a sinus is visualized via the scope as facilitated by theextended length of adequate illumination provided by the illuminationdevice.
 181. The method of claim 172, wherein the scope is inserted intoa nostril of the patient, and the guide is inserted adjacent the scope,and wherein advancement of the guide to place a distal end of the guideadjacent an approach to an ostium of a sinus is visualized via thescope.
 182. The method of claim 181, further comprising advancing thedistal end portion of the illuminating device distally of a distal endof the guide and distal of the limit of illumination of the scope toemit illumination, thereby extending a length of space that isvisualizable by the scope.
 183. The method of claim 182, furthercomprising advancing the distal end portion of the illuminating deviceinto and through the ostium, and visualizing the advancing of the distalend portion into the ostium via the scope.
 184. The method of claim 151,wherein the illuminating device comprises an illuminating guidewire,said method further comprising advancing a working device over theilluminating guidewire to position a working end of the working deviceat a target location; performing a surgical procedure with the workingdevice at the target location; and removing the working device from thepatient.
 185. A method of performing a minimally invasive surgicalprocedure, said method comprising the steps of: inserting a distal endportion of an illuminating guidewire internally into a patient, emittinglight from the distal end portion of the illuminating guidewire, whereina proximal end portion is connected to a power source to enable thedistal end portion to emit light; observing transillumination resultingfrom the light emitted from the distal end portion of the illuminatingguidewire that occurs on an external surface of the patient; correlatingthe location of the observed transillumination on the external surfaceof the patient with an internal location of the patient that underliesthe location of observed transillumination, to confirm positioning ofthe distal end portion of the illuminating guidewire; disconnecting theproximal end portion of the illuminating guidewire from the powersource; advancing a working device over the guidewire so that a proximalend of the guidewire extends proximally from the working device;reconnecting the proximal end portion of the illuminating guidewire tothe power source so that the distal end portion of the guidewire againemits light; positioning a working end of the working device at a targetlocation; and performing a surgical procedure with the working device atthe target location.
 186. The method of claim 185, further comprisingdisconnecting the proximal end portion of the illuminating guidewirefrom the power source; and removing the working device from the patientand from the guidewire.
 187. The method of claim 186, furthercomprising: advancing a second working device over the guidewire so thata proximal end of the guidewire extends proximally from the secondworking device; and reconnecting the proximal end portion of theilluminating guidewire to the power source so that the distal endportion of the guidewire again emits light.
 188. The method of claim185, wherein the illuminating guidewire includes at least oneillumination fiber extending from a proximal end of the guidewire to thedistal end portion, and the power source is a light source.
 189. Themethod of claim 185, wherein the illuminating guidewire includes atleast one laser fiber extending from a proximal end of the guidewire tothe distal end portion, and the power source is a laser light source.190. The method of claim 185, wherein the illuminating guidewireincludes a light emitting diode at the distal end portion and electricalwires extending through the guidewire, electrically connecting the lightemitting diode to the power source, and wherein the power source is anelectrical power source.
 191. A method for diagnosing and/or treatingsinusitis or another disorder affecting a nose, a sinus or otheranatomical structure of the ear, nose or throat in a human or animalpatient, said method comprising the steps of: advancing an introducingdevice through the nose and to a position where a distal end of theintroducing device is near an opening of a sinus; advancing a distal endportion of an illuminating device that emits light from a distal endportion thereof through the introducing device while a proximal end ofthe illuminating device is connected to a power source; and monitoring aposition of the distal end portion of the illuminating device distallyof the distal end of the introducing device by observingtransillumination on an external surface of the patient that resultsfrom the light emitted by the distal end portion.
 192. The method ofclaim 191, further comprising: advancing the distal end portion of theilluminating device through the opening of the sinus; and confirmingplacement of the distal end portion of the illuminating device in thesinus by observing the transillumination resulting from the lightemitted from the distal end portion of the illuminating device thatoccurs on the external surface of the patient, and correlating thelocation of the observed transillumination on the external surface ofthe patient with an internal location of the patient that underlies thelocation of observed transillumination.
 193. The method of claim 192,wherein the external surface is on the face of the patient.
 194. Themethod of claim 192, wherein the external surface is on the palate ofthe patient.
 195. The method of claim 192, wherein the illuminatingdevice comprises an illuminating guidewire, said method furthercomprising: disconnecting the proximal end of the illuminating guidewirefrom the power source, while maintaining the distal end portion of theilluminating guidewire substantially in its current position; advancinga working device that is positionable in an operative location anduseable to perform a diagnostic or therapeutic procedure there, over theguidewire so that the proximal end of the guidewire extends proximallyfrom the working device; reconnecting the proximal end of theilluminating guidewire to the power source so that the distal endportion of the guidewire again emits light; further advancing theworking device to a position wherein a working end of the working deviceis at the operative location; and performing a diagnostic or therapeuticprocedure with the working device at the operative location.
 196. Themethod of claim 192, further comprising performing a diagnostic ortherapeutic procedure with the illuminating device.
 197. The method ofclaim 195, wherein the operative location is the opening to the sinus.198. An illuminating guidewire device comprising: a flexible distal endportion; at least one light emitting element in said distal end portion;and at least one structure extending from a proximal end of said devicethrough said proximal end portion and at least part of said distal endportion to connect said at least one light emitting element with a powersource.